The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery (SRS) in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy (WBRT).

A randomized phase III study is started in Japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung, breast, and colorectal cancer.

Total of 270 patients will be accrued for this study from 21 institutions within three years. The primary endpoint is overall survival. The secondary endpoints are proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.

Eligibility

Ages Eligible for Study:

20 Years to 79 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

one to four brain metastases with a maximum diameter of 3 cm or more for the largest lesion and additional lesions not exceeding 3 cm in diameter

primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled

an age of 20-79 years

no prior surgery or irradiation for brain

adequate organ function

written informed consent(If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient is permitted)

Exclusion Criteria:

synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer

pregnant or breast-feeding women

severe mental disease

allergic to gadolinium contained contrast agents

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280475